Communication System with Enhanced Partial Power and Method of Manufacturing Same

ABSTRACT

The system of the present invention includes a conductive element, an electronic component, and a partial power source in the form of dissimilar materials. Upon contact with a conducting fluid, a voltage potential is created and the power source is completed, which activates the system. The electronic component controls the conductance between the dissimilar materials to produce a unique current signature. The system can also measure the conditions of the environment surrounding the system.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 12/564,017, filed on Sep. 21, 2009 and entitled “CommunicationSystem with Partial Power Source”, published on Apr. 1, 2010 as U.S.Publication No. US2010-0081894A1, which is a continuation-in-partapplication of U.S. patent application Ser. No. 11/912,475 filed Jun.23, 2008 and entitled “Pharma-Informatics System”, published on Nov. 20,2008 as U.S. Publication No. 2008-0284599A1 which application is a 371application of PCT Application No. PCT/US06/16370 filed Apr. 28, 2006and entitled “Pharma-Informatics System”; which application pursuant to35 U.S.C. §119 (e), claims priority to the filing dates of: U.S.Provisional Patent Application Ser. No. 60/676,145 filed Apr. 28, 2005and entitled “Pharma-Informatics System”; U.S. Provisional PatentApplication Ser. No. 60/694,078, filed Jun. 24, 2005, and entitled“Pharma-Informatics System”; U.S. Provisional Patent Application Ser.No. 60/713,680 filed Sep. 1, 2005 and entitled “Medical Diagnostic AndTreatment Platform Using Near-Field Wireless Communication OfInformation Within A Patient's Body”; and U.S. Provisional PatentApplication Ser. No. 60/790,335 filed Apr. 7, 2006 and entitled“Pharma-Informatics System”; the disclosures of which are hereinincorporated by reference.

This application is related to the following US Applications filedconcurrently herewith, the disclosures of which are incorporated hereinby reference: U.S. application Ser. No. ______ COMMUNICATION SYSTEM WITHREMOTE ACTIVATION (Attorney Docket No. PRTS-01000N2CIP (PRO-147)); U.S.application Ser. No. ______ COMMUNICATION SYSTEM WITH MULTIPLE TYPES OFPOWER (Attorney Docket No. PRTS-01000N2CIP2 (PRO-148)); U.S. applicationSer. No. ______ COMMUNICATION SYSTEM USING AN IMPLANTABLE DEVICE(Attorney Docket No. PRTS-01000N2CIP3 (PRO-149)); U.S. application Ser.No. ______ COMMUNICATION SYSTEM USING POLYPHARMACY CO-PACKAGEDMEDICATION DOSING UNIT (Attorney Docket No. PRTS-01000N2CIP5 (PRO-151));and U.S. application Ser. No. ______ COMMUNICATION SYSTEM INCORPORATEDIN AN INGESTIBLE PRODUCT (Attorney Docket No. PRTS-01000N2CIP6(PRO-152)).

FIELD

The present invention is related to communication systems for detectionof an event. More specifically, the present disclosure includes a systemthat includes a device with various power sources and communicationschemes.

INTRODUCTION

Ingestible devices that include electronic circuitry have been proposedfor use in a variety of different medical applications, including bothdiagnostic and therapeutic applications. These devices typically requirean internal power supply for operation. Examples of such ingestibledevices are ingestible electronic capsules which collect data as theypass through the body, and transmit the data to an external receiversystem. An example of this type of electronic capsule is an in-vivovideo camera. The swallowable capsule includes a camera system and anoptical system for imaging an area of interest onto the camera system.The transmitter transmits the video output of the camera system and thereception system receives the transmitted video output. Other examplesinclude an ingestible imaging device, which has an internal andself-contained power source, which obtains images from within bodylumens or cavities. The electronic circuit components of the device areenclosed by an inert indigestible housing (e.g. glass housing) thatpasses through the body internally. Other examples include an ingestibledata recorder capsule medical device. The electronic circuits of thedisclosed device (e.g. sensor, recorder, battery etc.) are housed in acapsule made of inert materials.

In other examples, fragile radio frequency identification (RFID) tagsare used in drug ingestion monitoring applications. In order for theRFID tags to be operational, each requires an internal power supply. TheRFID tags are antenna structures that are configured to transmit aradio-frequency signal through the body.

The problem these existing devices pose is that the power source isinternal to device and such power sources are costly to produce andpotentially harmful to the surrounding environment if the power sourceleaks or is damaged. Additionally, having antennas extending from thedevice is a concern as related to the antennas getting damaged orcausing a problem when the device is used in-vivo. Therefore, what isneeded is suitable system with circuitry that eliminates the need for aninternal power source and antennas.

SUMMARY

The present disclosure includes a system for producing a uniquesignature that indicates the occurrence of an event. The system includescircuitry and components that can be placed within certain environmentsthat include a conducting fluid. One example of such an environment isinside a container that houses the conducting fluid, such as a sealedbag with a solution, which includes an IV bag. Another example is withinthe body of a living organism, such as an animal or a human. The systemsare ingestible and/or digestible or partially digestible. The systemincludes dissimilar materials positioned on the framework such that whena conducting fluid comes into contact with the dissimilar materials, avoltage potential difference is created. The voltage potentialdifference, and hence the voltage, is used to power up control logicthat is positioned within the framework. Ions or current flows from thefirst dissimilar material to the second dissimilar material via thecontrol logic and then through the conducting fluid to complete acircuit. The control logic controls the conductance between the twodissimilar materials and, hence, controls or modulates the conductance.

As the ingestible circuitry is made up of ingestible, and evendigestible, components, the ingestible circuitry results in little, ifany, unwanted side effects, even when employed in chronic situations.Examples of the range of components that may be included are: logicand/or memory elements; effectors; a signal transmission element; and apassive element, such as a resistor or inductor. The one or morecomponents on the surface of the support may be laid out in anyconvenient configuration. Where two or more components are present onthe surface of the solid support, interconnects may be provided. All ofthe components and the support of the ingestible circuitry areingestible, and in certain instances digestible or partially digestible.Furthermore, the circuitry is manufactured according to a process toenhance adhesion of the materials.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 shows a pharmaceutical product with an event indicator systemaccording to the teaching of the present invention, wherein the productand the event indicator system combination are within the body.

FIG. 2A shows the pharmaceutical product of FIG. 1 with the eventindicator system on the exterior of the pharmaceutical product.

FIG. 2B shows the pharmaceutical product of FIG. 1 with the eventindicator system positioned inside the pharmaceutical product.

FIG. 3 is a block diagram representation of one aspect of the eventindicator system with dissimilar metals positioned on opposite ends.

FIG. 4 is a block diagram representation of another aspect of the eventindicator system with dissimilar metals positioned on the same end andseparated by a non-conducting material.

FIG. 5 shows ionic transfer or the current path through a conductingfluid when the event indicator system of FIG. 3 is in contact withconducting liquid and in an active state.

FIG. 5A shows an exploded view of the surface of dissimilar materials ofFIG. 5.

FIG. 5B shows the event indicator system of FIG. 5 with a pH sensorunit.

FIG. 5C shows the event indicator system in accordance with anotheraspect of the present invention.

FIG. 6 is a block diagram illustration of one aspect of the controldevice used in the system of FIGS. 3 and 4.

FIG. 7 shows a cross sectional side view of the event indicator systemin accordance with the present invention.

FIG. 8 is an exploded view of two components of the event indicatorsystem of FIG. 7 in accordance with the present invention.

FIG. 9 is an assembly process of a portion of the event indicator systemof FIG. 7 in accordance with the present invention.

FIG. 10 shows a wafer with multiple event indicator systems inaccordance with the present invention.

FIG. 11 shows a non-conducting membrane sheet with holes for receiving adevice forming part of the event indicator system of FIG. 7 inaccordance with the present invention.

DETAILED DESCRIPTION

The present disclosure includes multiple aspects for indicating theoccurrence of an event. As described in more detail below, a system ofthe present invention is used with a conducting fluid to indicate theevent marked by contact between the conducting fluid and the system. Forexample, the system of the present disclosure may be used withpharmaceutical product and the event that is indicated is when theproduct is taken or ingested. The term “ingested” or “ingest” or“ingesting” is understood to mean any introduction of the systeminternal to the body. For example, ingesting includes simply placing thesystem in the mouth all the way to the descending colon. Thus, the termingesting refers to any instant in time when the system is introduced toan environment that contains a conducting fluid. Another example wouldbe a situation when a non-conducting fluid is mixed with a conductingfluid. In such a situation the system would be present in thenon-conduction fluid and when the two fluids are mixed, the system comesinto contact with the conducting fluid and the system is activated. Yetanother example would be the situation when the presence of certainconducting fluids needed to be detected. In such instances, the presenceof the system, which would be activated, within the conducting fluidcould be detected and, hence, the presence of the respective fluid wouldbe detected.

Referring again to the instance where the system is used with theproduct that is ingested by the living organism, when the product thatincludes the system is taken or ingested, the device comes into contactwith the conducting liquid of the body. When the system of the presentinvention comes into contact with the body fluid, a voltage potential iscreated and the system is activated. A portion of the power source isprovided by the device, while another portion of the power source isprovided by the conducting fluid, which is discussed in detail below.

Referring now to FIG. 1, an ingestible product 14 that includes a systemof the present invention is shown inside the body. The product 14 isconfigured as an orally ingestible pharmaceutical formulation in theform of a pill or capsule. Upon ingestion, the pill moves to thestomach. Upon reaching the stomach, the product 14 is in contact withstomach fluid 18 and undergoes a chemical reaction with the variousmaterials in the stomach fluid 18, such as hydrochloric acid and otherdigestive agents. The system of the present invention is discussed inreference to a pharmaceutical environment. However, the scope of thepresent invention is not limited thereby. The present invention can beused in any environment where a conducting fluid is present or becomespresent through mixing of two or more components that result in aconducting liquid.

Referring now to FIG. 2A, a pharmaceutical product 10, similar to theproduct 14 of FIG. 1, is shown with a system 12, such as an ingestibleevent marker or an ionic emission module. The scope of the presentinvention is not limited by the shape or type of the product 10. Forexample, it will be clear to one skilled in the art that the product 10can be a capsule, a time-release oral dosage, a tablet, a gel cap, asub-lingual tablet, or any oral dosage product that can be combined withthe system 12. In the referenced aspect, the product 10 has the system12 secured to the exterior using known methods of securing micro-devicesto the exterior of pharmaceutical products. Example of methods forsecuring the micro-device to the product is disclosed in U.S.Provisional Application No. 61/142,849 filed on Jan 1, 2009 and entitled“HIGH-THROUGHPUT PRODUCTION OF INGESTIBLE EVENT MARKERS” as well as U.S.Provisional Application No. 61/177,611 filed on May 12, 2009 andentitled “INGESTIBLE EVENT MARKERS COMPRISING AN IDENTIFIER AND ANINGESTIBLE COMPONENT”, the entire disclosure of each is incorporatedherein by reference. Once ingested, the system 12 comes into contactwith body liquids and the system 12 is activated. The system 12 uses thevoltage potential difference to power up and thereafter modulatesconductance to create a unique and identifiable current signature. Uponactivation, the system 12 controls the conductance and, hence, currentflow to produce the current signature.

There are various reasons for delaying the activation of the system 12.In order to delay the activation of the system 12, the system 12 may becoated with a shielding material or protective layer. The layer isdissolved over a period of time, thereby allowing the system 12 to beactivated when the product 10 has reached a target location.

Referring now to FIG. 2B, a pharmaceutical product 20, similar to theproduct 14 of FIG. 1, is shown with a system 22, such as an ingestibleevent marker or an identifiable emission module. The scope of thepresent invention is not limited by the environment to which the system22 is introduced. For example, the system 22 can be enclosed in acapsule that is taken in addition to/independently from thepharmaceutical product. The capsule may be simply a carrier for thesystem 22 and may not contain any product. Furthermore, the scope of thepresent invention is not limited by the shape or type of product 20. Forexample, it will be clear to one skilled in the art that the product 20can be a capsule, a time-release oral dosage, a tablet, a gel capsule, asub-lingual tablet, or any oral dosage product. In the referencedaspect, the product 20 has the system 22 positioned inside or secured tothe interior of the product 20. In one aspect, the system 22 is securedto the interior wall of the product 20. When the system 22 is positionedinside a gel capsule, then the content of the gel capsule is anon-conducting gel-liquid. On the other hand, if the content of the gelcapsule is a conducting gel-liquid, then in an alternative aspect, thesystem 22 is coated with a protective cover to prevent unwantedactivation by the gel capsule content. If the content of the capsule isa dry powder or microspheres, then the system 22 is positioned or placedwithin the capsule. If the product 20 is a tablet or hard pill, then thesystem 22 is held in place inside the tablet. Once ingested, the product20 containing the system 22 is dissolved. The system 22 comes intocontact with body liquids and the system 22 is activated. Depending onthe product 20, the system 22 may be positioned in either a near-centralor near-perimeter position depending on the desired activation delaybetween the time of initial ingestion and activation of the system 22.For example, a central position for the system 22 means that it willtake longer for the system 22 to be in contact with the conductingliquid and, hence, it will take longer for the system 22 to beactivated. Therefore, it will take longer for the occurrence of theevent to be detected.

Referring now to FIG. 3, in one aspect, the systems 12 and 22 of FIGS.2A and 2B, respectively, are shown in more detail as system 30. Thesystem 30 can be used in association with any pharmaceutical product, asmentioned above, to determine when a patient takes the pharmaceuticalproduct. As indicated above, the scope of the present invention is notlimited by the environment and the product that is used with the system30. For example, the system 30 may be placed within a capsule and thecapsule is placed within the conducting liquid. The capsule would thendissolve over a period of time and release the system 30 into theconducting liquid. Thus, in one aspect, the capsule would contain thesystem 30 and no product. Such a capsule may then be used in anyenvironment where a conducting liquid is present and with any product.For example, the capsule may be dropped into a container filled with jetfuel, salt water, tomato sauce, motor oil, or any similar product.Additionally, the capsule containing the system 30 may be ingested atthe same time that any pharmaceutical product is ingested in order torecord the occurrence of the event, such as when the product was taken.

In the specific example of the system 30 combined with thepharmaceutical product, as the product or pill is ingested, the system30 is activated. The system 30 controls conductance to produce a uniquecurrent signature that is detected, thereby signifying that thepharmaceutical product has been taken. The system 30 includes aframework 32. The framework 32 is a chassis for the system 30 andmultiple components are attached to, deposited upon, or secured to theframework 32. In this aspect of the system 30, a digestible material 34is physically associated with the framework 32. The material 34 may bechemically deposited on, evaporated onto, secured to, or built-up on theframework all of which may be referred to herein as “deposit” withrespect to the framework 32. The material 34 is deposited on one side ofthe framework 32. The materials of interest that can be used as material34 include, but are not limited to: Cu or CuI. The material 34 isdeposited by physical vapor deposition, electrodeposition, or plasmadeposition, among other protocols. The material 34 may be from about0.05 to about 500 μm thick, such as from about 5 to about 100 μm thick.The shape is controlled by shadow mask deposition, or photolithographyand etching. Additionally, even though only one region is shown fordepositing the material, each system 30 may contain two or moreelectrically unique regions where the material 34 may be deposited, asdesired. The various methods for depositing the materials onto theframework 32 are discussed in greater detail with respect to FIGS. 7-9below.

At a different side, which is the opposite side as shown in FIG. 3,another digestible material 36 is deposited, such that materials 34 and36 are dissimilar. Although not shown, the different side selected maybe the side next to the side selected for the material 34. The scope ofthe present invention is not limited by the side selected and the term“different side” can mean any of the multiple sides that are differentfrom the first selected side. Furthermore, even though the shape of thesystem is shown as a square, the shape maybe any geometrically suitableshape. Material 34 and 36 are selected such that they produce a voltagepotential difference when the system 30 is in contact with conductingliquid, such as body fluids. The materials of interest for material 36include, but are not limited to: Mg, Zn, or other electronegativemetals. As indicated above with respect to the material 34, the material36 may be chemically deposited on, evaporated onto, secured to, orbuilt-up on the framework. Also, an adhesion layer may be necessary tohelp the material 36 (as well as material 34 when needed) to adhere tothe framework 32. Typical adhesion layers for the material 36 are Ti,TiW, Cr or similar material. Anode material and the adhesion layer maybe deposited by physical vapor deposition, electrodeposition or plasmadeposition. The material 36 may be from about 0.05 to about 500 μmthick, such as from about 5 to about 100 μm thick. However, the scope ofthe present invention is not limited by the thickness of any of thematerials nor by the type of process used to deposit or secure thematerials to the framework 32.

According to the disclosure set forth, the materials 34 and 36 can beany pair of materials with different electrochemical potentials.Additionally, in the aspects wherein the system 30 is used in-vivo, thematerials 34 and 36 may be vitamins that can be absorbed. Morespecifically, the materials 34 and 36 can be made of any two materialsappropriate for the environment in which the system 30 will beoperating. For example, when used with an ingestible product, thematerials 34 and 36 are any pair of materials with differentelectrochemical potentials that are ingestible. An illustrative exampleincludes the instance when the system 30 is in contact with an ionicsolution, such as stomach acids. Suitable materials are not restrictedto metals, and in certain aspects the paired materials are chosen frommetals and non-metals, e.g., a pair made up of a metal (such as Mg) anda salt (such as CuCl or CuI). With respect to the active electrodematerials, any pairing of substances—metals, salts, or intercalationcompounds—with suitably different electrochemical potentials (voltage)and low interfacial resistance are suitable.

Materials and pairings of interest include, but are not limited to,those reported in Table 1 below. In one aspect, one or both of themetals may be doped with a non-metal, e.g., to enhance the voltagepotential created between the materials as they come into contact with aconducting liquid. Non-metals that may be used as doping agents incertain aspects include, but are not limited to: sulfur, iodine and thelike. In another aspect, the materials are copper iodine (CuI) as theanode and magnesium (Mg) as the cathode. Aspects of the presentinvention use electrode materials that are not harmful to the humanbody.

TABLE 1 Anode Cathode Metals Magnesium, Zinc Sodium, Lithium Iron SaltsCopper salts: iodide, chloride, bromide, sulfate, formate, (other anionspossible) Fe³⁺ salts: e.g. orthophosphate, pyrophosphate, (other anionspossible) Oxygen or Hydrogen ion (H+) on platinum, gold or othercatalytic surfaces Intercalation Graphite with Li, Vanadium oxidecompounds K, Ca, Na, Mg Manganese oxide

Thus, when the system 30 is in contact with the conducting liquid, acurrent path, an example is shown in FIG. 5, is formed through theconducting liquid between material 34 and 36. A control device 38 issecured to the framework 32 and electrically coupled to the materials 34and 36. The control device 38 includes electronic circuitry, for examplecontrol logic that is capable of controlling and altering theconductance between the materials 34 and 36.

The voltage potential created between the materials 34 and 36 providesthe power for operating the system as well as produces the current flowthrough the conducting fluid and the system. In one aspect, the systemoperates in direct current mode. In an alternative aspect, the systemcontrols the direction of the current so that the direction of currentis reversed in a cyclic manner, similar to alternating current. As thesystem reaches the conducting fluid or the electrolyte, where the fluidor electrolyte component is provided by a physiological fluid, e.g.,stomach acid, the path for current flow between the materials 34 and 36is completed external to the system 30; the current path through thesystem 30 is controlled by the control device 38. Completion of thecurrent path allows for the current to flow and in turn a receiver, notshown, can detect the presence of the current and recognize that thesystem 30 has been activate and the desired event is occurring or hasoccurred.

In one aspect, the two materials 34 and 36 are similar in function tothe two electrodes needed for a direct current power source, such as abattery. The conducting liquid acts as the electrolyte needed tocomplete the power source. The completed power source described isdefined by the electrochemical reaction between the materials 34 and 36of the system 30 and enabled by the fluids of the body. The completedpower source may be viewed as a power source that exploitselectrochemical conduction in an ionic or a conducting solution such asgastric fluid, blood, or other bodily fluids and some tissues.Additionally, the environment may be something other than a body and theliquid may be any conducting liquid. For example, the conducting fluidmay be salt water or a metallic based paint.

In certain aspects, these two materials are shielded from thesurrounding environment by an additional layer of material. Accordingly,when the shield is dissolved and the two dissimilar materials areexposed to the target site, a voltage potential is generated.

In certain aspects, the complete power source or supply is one that ismade up of active electrode materials, electrolytes, and inactivematerials, such as current collectors, packaging, etc. The activematerials are any pair of materials with different electrochemicalpotentials. Suitable materials are not restricted to metals, and incertain aspects the paired materials are chosen from metals andnon-metals, e.g., a pair made up of a metal (such as Mg) and a salt(such as CuI). With respect to the active electrode materials, anypairing of substances—metals, salts, or intercalation compounds—withsuitably different electrochemical potentials (voltage) and lowinterfacial resistance are suitable.

A variety of different materials may be employed as the materials thatform the electrodes. In certain aspects, electrode materials are chosento provide for a voltage upon contact with the target physiologicalsite, e.g., the stomach, sufficient to drive the system of theidentifier. In certain aspects, the voltage provided by the electrodematerials upon contact of the metals of the power source with the targetphysiological site is 0.001 V or higher, including 0.01 V or higher,such as 0.1 V or higher, e.g., 0.3 V or higher, including 0.5 volts orhigher, and including 1.0 volts or higher, where in certain aspects, thevoltage ranges from about 0.001 to about 10 volts, such as from about0.01 to about 10 V.

Referring again to FIG. 3, the materials 34 and 36 provide the voltagepotential to activate the control device 38. Once the control device 38is activated or powered up, the control device 38 can alter conductancebetween the materials 34 and 36 in a unique manner. By altering theconductance between materials 34 and 36, the control device 38 iscapable of controlling the magnitude of the current through theconducting liquid that surrounds the system 30. This produces a uniquecurrent signature that can be detected and measured by a receiver (notshown), which can be positioned internal or external to the body. Inaddition to controlling the magnitude of the current path between thematerials, non-conducting materials, membrane, or “skirt” are used toincrease the “length” of the current path and, hence, act to boost theconductance path, as disclosed in the U.S. patent application Ser. No.12/238,345 entitled, “In-Body Device with Virtual Dipole SignalAmplification” filed Sep. 25, 2008, the entire content of which isincorporated herein by reference. Alternatively, throughout thedisclosure herein, the terms “non-conducting material”, “membrane”, and“skirt” are used interchangeably with the term “current path extender”without impacting the scope or the present aspects and the claimsherein. The skirt, shown in portion at 35 and 37, respectively, may beassociated with, e.g., secured to, the framework 32. Various shapes andconfigurations for the skirt are contemplated as within the scope of thepresent invention. For example, the system 30 may be surrounded entirelyor partially by the skirt and the skirt maybe positioned along a centralaxis of the system 30 or off-center relative to a central axis. Thus,the scope of the present invention as claimed herein is not limited bythe shape or size of the skirt. Furthermore, in other aspects, thematerials 34 and 36 may be separated by one skirt that is positioned inany defined region between the materials 34 and 36.

Referring now to FIG. 4, in another aspect, the systems 12 and 22 ofFIGS. 2A and 2B, respectively, are shown in more detail as system 40.The system 40 includes a framework 42. The framework 42 is similar tothe framework 32 of FIG. 3. In this aspect of the system 40, adigestible or dissolvable material 44 is deposited on a portion of oneside of the framework 42. At a different portion of the same side of theframework 42, another digestible material 46 is deposited, such thatmaterials 44 and 46 are dissimilar. More specifically, material 44 and46 are selected such that they form a voltage potential difference whenin contact with a conducting liquid, such as body fluids. Thus, when thesystem 40 is in contact with and/or partially in contact with theconducting liquid, then a current path, an example is shown in FIG. 5,is formed through the conducting liquid between material 44 and 46. Acontrol device 48 is secured to the framework 42 and electricallycoupled to the materials 44 and 46. The control device 48 includeselectronic circuitry that is capable of controlling part of theconductance path between the materials 44 and 46. The materials 44 and46 are separated by a non-conducting skirt 49. Various examples of theskirt 49 are disclosed in U.S. Provisional Application No. 61/173,511filed on Apr. 28, 2009 and entitled “HIGHLY RELIABLE INGESTIBLE EVENTMARKERS AND METHODS OF USING SAME” and U.S. Provisional Application No.61/173,564 filed on Apr. 28, 2009 and entitled “INGESTIBLE EVENT MARKERSHAVING SIGNAL AMPLIFIERS THAT COMPRISE AN ACTIVE AGENT”; as well as U.S.application Ser. No. 12/238,345 filed Sep. 25, 2008 and entitled“IN-BODY DEVICE WITH VIRTUAL DIPOLE SIGNAL AMPLIFICATION”; the entiredisclosure of each is incorporated herein by reference.

Once the control device 48 is activated or powered up, the controldevice 48 can alter conductance between the materials 44 and 46. Thus,the control device 48 is capable of controlling the magnitude of thecurrent through the conducting liquid that surrounds the system 40. Asindicated above with respect to system 30, a unique current signaturethat is associated with the system 40 can be detected by a receiver (notshown) to mark the activation of the system 40. In order to increase the“length” of the current path the size of the skirt 49 is altered. Thelonger the current path, the easier it may be for the receiver to detectthe current.

Referring now to FIG. 5, the system 30 of FIG. 3 is shown in anactivated state and in contact with conducting liquid. The system 30 isgrounded through ground contact 52. For example, when the system 30 isin contact with a conducting fluid, the conducting fluid provides theground. The system 30 also includes a sensor module 74, which isdescribed in greater detail with respect to FIG. 6. Ion or current paths50 extend between material 34 to material 36 and flow through theconducting fluid in contact with the system 30. The voltage potentialcreated between the material 34 and 36 is created through chemicalreactions between materials 34/36 and the conducting fluid.

If the conditions of the environment change to become favorable tocommunication, as determined by the measurements of the environment,then the unit 75 sends a signal to the control device 38 to alter theconductance between the materials 34 and 36 to allow for communicationusing the current signature of the system 30. Thus, if the system 30 hasbeen deactivated and the impedance of the environment is suitable forcommunication, then the system 30 can be activated again.

Referring now to FIG. 5A, this shows an exploded view of the surface ofthe material 34. In one aspect, the surface of the material 34 is notplanar, but rather an irregular surface. The irregular surface increasesthe surface area of the material and, hence, the area that comes incontact with the conducting fluid. In one aspect, at the surface of thematerial 34, there is an electrochemical reaction between the material34 and the surrounding conducting fluid such that mass is exchanged withthe conducting fluid. The term “mass” as used here includes any ionic ornon-ionic species that may be added or removed from the conductive fluidas part of the electrochemical reactions occurring on material 34. Oneexample includes the instant where the material is CuCl and when incontact with the conducting fluid, CuCl is converted to Cu metal (solid)and Cl— is released into the solution. The flow of positive ions intothe conducting fluid is depicted by the current path 50. Negative ionsflow in the opposite direction. In a similar manner, there is anelectrochemical reaction involving the material 36 that results in ionsreleased or removed from the conducting fluid. In this example, therelease of negative ions at the material 34 and release of positive ionsby the material 36 are related to each other through the current flowthat is controlled by the control device 38. The rate of reaction andhence the ionic emission rate or current, is controlled by the controldevice 38. The control device 38 can increase or decrease the rate ofion flow by altering its internal conductance, which alters theimpedance, and therefore the current flow and reaction rates at thematerials 34 and 36. Through controlling the reaction rates, the system30 can encode information in the ionic flow. Thus, the system 30 encodesinformation using ionic emission or flow.

The control device 38 can vary the duration of ionic flow or currentwhile keeping the current or ionic flow magnitude near constant, similarto when the frequency is modulated and the amplitude is constant. Also,the control device 38 can vary the level of the ionic flow rate or themagnitude of the current flow while keeping the duration near constant.Thus, using various combinations of changes in duration and altering therate or magnitude, the control device 38 encodes information in thecurrent or the ionic flow. For example, the control device 38 may use,but is not limited to any of the following techniques, including BinaryPhase-Shift Keying (PSK), Frequency modulation, Amplitude modulation,on-off keying, and PSK with on-off keying.

As indicated above, the various aspects disclosed herein, such assystems 30 and 40 of FIGS. 3 and 4, respectively, include electroniccomponents as part of the control device 38 or the control device 48.Components that may be present include but are not limited to: logicand/or memory elements, an integrated circuit, an inductor, a resistor,and sensors for measuring various parameters. Each component may besecured to the framework and/or to another component. The components onthe surface of the support may be laid out in any convenientconfiguration. Where two or more components are present on the surfaceof the solid support, interconnects may be provided.

As indicated above, the system, such as control devices 30 and 40,control the conductance between the dissimilar materials and, hence, therate of ionic flow or current. Through altering the conductance in aspecific manner the system is capable of encoding information in theionic flow and the current signature. The ionic flow or the currentsignature is used to uniquely identify the specific system.Additionally, the systems 30 and 40 are capable of producing variousdifferent unique patterns or signatures and, thus, provide additionalinformation. For example, a second current signature based on a secondconductance alteration pattern may be used to provide additionalinformation, which information may be related to the physicalenvironment. To further illustrate, a first current signature may be avery low current state that maintains an oscillator on the chip and asecond current signature may be a current state at least a factor of tenhigher than the current state associated with the first currentsignature.

Referring now to FIG. 6, a block diagram representation of the controldevice 38 is shown. The device 30 includes a control module 62, acounter or clock 64, and a memory 66. Additionally, the control device38 is shown to include a sensor module 72 as well as the sensor module74, which was referenced in FIG. 5. The control module 62 has an input68 electrically coupled to the material 34 and an output 70 electricallycoupled to the material 36. The control module 62, the clock 64, thememory 66, and the sensor modules 72/74 also have power inputs (some notshown). The power for each of these components is supplied by thevoltage potential produced by the chemical reaction between materials 34and 36 and the conducting fluid, when the system 30 is in contact withthe conducting fluid. The control module 62 controls the conductancethrough logic that alters the overall impedance of the system 30. Thecontrol module 62 is electrically coupled to the clock 64. The clock 64provides a clock cycle to the control module 62. Based upon theprogrammed characteristics of the control module 62, when a set numberof clock cycles have passed, the control module 62 alters theconductance characteristics between materials 34 and 36. This cycle isrepeated and thereby the control device 38 produces a unique currentsignature characteristic. The control module 62 is also electricallycoupled to the memory 66. Both the clock 64 and the memory 66 arepowered by the voltage potential created between the materials 34 and36.

The control module 62 is also electrically coupled to and incommunication with the sensor modules 72 and 74. In the aspect shown,the sensor module 72 is part of the control device 38 and the sensormodule 74 is a separate component. In alternative aspects, either one ofthe sensor modules 72 and 74 can be used without the other and the scopeof the present invention is not limited by the structural or functionallocation of the sensor modules 72 or 74. Additionally, any component ofthe system 30 may be functionally or structurally moved, combined, orrepositioned without limiting the scope of the present invention asclaimed. Thus, it is possible to have one single structure, for examplea processor, which is designed to perform the functions of all of thefollowing modules: the control module 62, the clock 64, the memory 66,and the sensor module 72 or 74. On the other hand, it is also within thescope of the present invention to have each of these functionalcomponents located in independent structures that are linkedelectrically and able to communicate.

Referring again to FIG. 6, the sensor modules 72 or 74 can include anyof the following sensors: temperature, pressure, pH level, andconductivity. In one aspect, the sensor modules 72 or 74 gatherinformation from the environment and communicate the analog informationto the control module 62. The control module then converts the analoginformation to digital information and the digital information isencoded in the current flow or the rate of the transfer of mass thatproduces the ionic flow. In another aspect, the sensor modules 72 or 74gather information from the environment and convert the analoginformation to digital information and then communicate the digitalinformation to control module 62. In the aspect shown in FIGS. 5, thesensor modules 74 is shown as being electrically coupled to the material34 and 36 as well as the control device 38. In another aspect, as shownin FIG. 6, the sensor module 74 is electrically coupled to the controldevice 38 at connection 78. The connection 78 acts as both a source forpower supply to the sensor module 74 and a communication channel betweenthe sensor module 74 and the control device 38.

Referring now to FIG. 5B, the system 30 includes a pH sensor module 76connected to a material 39, which is selected in accordance with thespecific type of sensing function being performed. The pH sensor module76 is also connected to the control device 38. The material 39 iselectrically isolated from the material 34 by a non-conductive barrier55. In one aspect, the material 39 is platinum. In operation, the pHsensor module 76 uses the voltage potential difference between thematerials 34/36. The pH sensor module 76 measures the voltage potentialdifference between the material 34 and the material 39 and records thatvalue for later comparison. The pH sensor module 76 also measures thevoltage potential difference between the material 39 and the material 36and records that value for later comparison. The pH sensor module 76calculates the pH level of the surrounding environment using the voltagepotential values. The pH sensor module 76 provides that information tothe control device 38. The control device 38 varies the rate of thetransfer of mass that produces the ionic transfer and the current flowto encode the information relevant to the pH level in the ionictransfer, which can be detected by a receiver (not shown). Thus, thesystem 30 can determine and provide the information related to the pHlevel to a source external to the environment.

As indicated above, the control device 38 can be programmed in advanceto output a pre-defined current signature. In another aspect, the systemcan include a receiver system that can receive programming informationwhen the system is activated. In another aspect, not shown, the switch64 and the memory 66 can be combined into one device.

In addition to the above components, the system 30 may also include oneor other electronic components. Electrical components of interestinclude, but are not limited to: additional logic and/or memoryelements, e.g., in the form of an integrated circuit; a power regulationdevice, e.g., battery, fuel cell or capacitor; a sensor, a stimulator,etc.; a signal transmission element, e.g., in the form of an antenna,electrode, coil, etc.; a passive element, e.g., an inductor, resistor,etc.

Referring now to FIG. 5C, the system 30 is shown with the skirt portions35 and 37 secured to the framework 32, as discussed in detail below. Inaccordance with one aspect of the present invention, the material 34 andthe material 36 extend beyond the framework 32 onto the skirt portions35 and 37. In another example in accordance with the present invention,the materials 34 and 36 can extend to the edge of the skirt portions 35and 37. The increase in the area of the materials 34 and 36 results inan increase in the power supplied.

Referring now to FIG. 7, a cross-sectional view is shown of the system30 with a first material region 34 a and a second material region 36 aon the framework 32. The first material region 34 a includes an adheringmaterial 86. The adhering material 86 can be any material selected toadhere and hold onto a first material region 88, which material region88 is made of CuCl in accordance with one aspect of the presentinvention as discussed above with respect to the first material 34. Thesecond material region 36 a includes a transition metal 96 that is madeof any transition metal, for example titanium in accordance with oneaspect of the present invention. The second material region 36 a alsoincludes a second material region 98, which is made of magnesium (Mg) inaccordance with one aspect of the present invention as discussed abovewith respect to the second material 36.

Referring now to FIG. 8, an exploded view of the material 86 and thematerial region 88 is shown. The material 86 is made of a non-reactiveand conducting material, for example gold. To enhance the adhesionproperties of the material 86 to the material region 88, the material 86has an unfinished or rough surface. The material 86 is deposited ontothe framework 32. Additionally, according to one aspect of the presentinvention, the material 86 defines a plurality of holes 87 spaced adistance DD from the edge of the framework 32 corresponding to the edgeof the material 86. The distance DD is the minimum distance that isneeded to separate the holes 87 from the edge of the material 86 andallow all the of the holes 87 to fall within a boundary 89 so that theedge of the material region 88 is not positioned over any hole; thisdesign enhances the adhesion property and characteristics of thematerial 86 to the material region 88.

Referring now to FIG. 9, a process of securing the metal 96 to theframework 32 is shown. Initially the metal 96 is deposited onto theframework 32. Then the metal 86 with the framework 32 is heated. Thenthe surface of the metal 96 is cleaned using, for example, an ion guncleaner. Then the magnesium is deposited onto the cleaned surface of themetal 86 to form the material region 98.

In accordance with another aspect of the present invention, a pluralityof frameworks 32, as shown in FIG. 1, are built on a wafer 100, as shownin the top view illustration of FIG. 10. The wafer 100 can include anynumber of frameworks 32. Once the wafer 100 is complete, then eachcomplete framework 32 is cut from the wafer 100 and inserted or pressfitted or placed into an opening 112 of FIG. 11 of a sheet 110 toproduce the system 12, 22, 30, or 40 as shown and discussed about inaccordance with the various aspects of the present invention. Theopening 112 is matingly cut to the shape of the framework 32. The sheet110 is then passed through a punch press (not shown) that punches outeach of systems 12, 22, 30, or 40 as noted.

In certain aspects, the ingestible circuitry includes a coating layer.In accordance with one aspect of the present invention, the protectivecoating may be applied to the wafer 100 using a spinning process priorto removal of the framework 32 from the wafer 100 of FIG. 10. Inaccordance with another aspect of the present invention, the protectivecoating may be applied to the system, for example the system 30, afterbeing punched out or cut out from the sheet 110 of FIG. 11. The purposeof this coating layer can vary, e.g., to protect the circuitry, the chipand/or the battery, or any components during processing, during storage,or even during ingestion. In such instances, a coating on top of thecircuitry may be included. Also of interest are coatings that aredesigned to protect the ingestible circuitry during storage, butdissolve immediately during use. For example, coatings that dissolveupon contact with an aqueous fluid, e.g. stomach fluid, or theconducting fluid as referenced above. Also of interest are protectiveprocessing coatings that are employed to allow the use of processingsteps that would otherwise damage certain components of the device. Forexample, in aspects where a chip with dissimilar material deposited onthe top and bottom is produced, the product needs to be diced. However,the dicing process can scratch off the dissimilar material, and alsothere might be liquid involved which would cause the dissimilarmaterials to discharge or dissolve. In such instances, a protectivecoating on the materials prevents mechanical or liquid contact with thecomponent during processing can be employed.

Another purpose of the dissolvable coatings may be to delay activationof the device. For example, the coating that sits on the dissimilarmaterial and takes a certain period of time, e.g., five minutes, todissolve upon contact with stomach fluid may be employed. The coatingcan also be an environmentally sensitive coating, e.g., a temperature orpH sensitive coating, or other chemically sensitive coating thatprovides for dissolution in a controlled fashion and allows one toactivate the device when desired. Coatings that survive the stomach butdissolve in the intestine are also of interest, e.g., where one desiresto delay activation until the device leaves the stomach. An example ofsuch a coating is a polymer that is insoluble at low pH, but becomessoluble at a higher pH. Also of interest are pharmaceutical formulationprotective coatings, e.g., a gel cap liquid protective coating thatprevents the circuit from being activated by liquid of the gel cap.

Identifiers of interest include two dissimilar electrochemicalmaterials, which act similar to the electrodes (e.g., anode and cathode)of a power source. The reference to an electrode or anode or cathode areused here merely as illustrative examples. The scope of the presentinvention is not limited by the label used and includes the aspectwherein the voltage potential is created between two dissimilarmaterials. Thus, when reference is made to an electrode, anode, orcathode it is intended as a reference to a voltage potential createdbetween two dissimilar materials.

When the materials are exposed and come into contact with the bodyfluid, such as stomach acid or other types of fluid (either alone or incombination with a dried conductive medium precursor), a potentialdifference, that is, a voltage, is generated between the electrodes as aresult of the respective oxidation and reduction reactions incurred tothe two electrode materials. A voltaic cell, or battery, can thereby beproduced. Accordingly, in aspects of the invention, such power suppliesare configured such that when the two dissimilar materials are exposedto the target site, e.g., the stomach, the digestive tract, etc., avoltage is generated.

In certain aspects, one or both of the metals may be doped with anon-metal, e.g., to enhance the voltage output of the battery.Non-metals that may be used as doping agents in certain aspects include,but are not limited to: sulfur, iodine and the like.

It is to be understood that this invention is not limited to particularembodiments or aspects described and, as such, may vary. It is also tobe understood that the terminology used herein is for the purpose ofdescribing particular aspects only, and is not intended to be limiting,since the scope of the present invention will be limited only by theappended claims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimit of that range and any other stated or intervening value in thatstated range, is encompassed within the invention. The upper and lowerlimits of these smaller ranges may independently be included in thesmaller ranges and are also encompassed within the invention, subject toany specifically excluded limit in the stated range. Where the statedrange includes one or both of the limits, ranges excluding either orboth of those included limits are also included in the invention.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although any methods andmaterials similar or equivalent to those described herein can also beused in the practice or testing of the present invention, representativeillustrative methods and materials are now described.

All publications and patents cited in this specification are hereinincorporated by reference as if each individual publication or patentwere specifically and individually indicated to be incorporated byreference and are incorporated herein by reference to disclose anddescribe the methods and/or materials in connection with which thepublications are cited. The citation of any publication is for itsdisclosure prior to the filing date and should not be construed as anadmission that the present invention is not entitled to antedate suchpublication by virtue of prior invention. Further, the dates ofpublication provided may be different from the actual publication dateswhich may need to be independently confirmed.

It is noted that, as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise. It is further noted that the claimsmay be drafted to exclude any optional element. As such, this statementis intended to serve as antecedent basis for use of such exclusiveterminology as “solely,” “only” and the like in connection with therecitation of claim elements, or use of a “negative” limitation.

As will be apparent to those of skill in the art upon reading thisdisclosure, each of the individual aspects described and illustratedherein has discrete components and features which may be readilyseparated from or combined with the features of any of the other severalaspects without departing from the scope or spirit of the presentinvention. Any recited method can be carried out in the order of eventsrecited or in any other order which is logically possible.

Although the foregoing invention has been described in some detail byway of illustration and example for purposes of clarity ofunderstanding, it is readily apparent to those of ordinary skill in theart in light of the teachings of this invention that certain changes andmodifications may be made thereto without departing from the spirit orscope of the appended claims.

Accordingly, the preceding merely illustrates the principles of theinvention. It will be appreciated that those skilled in the art will beable to devise various arrangements which, although not explicitlydescribed or shown herein, embody the principles of the invention andare included within its spirit and scope. Furthermore, all examples andconditional language recited herein are principally intended to aid thereader in understanding the principles of the invention and the conceptscontributed by the inventors to furthering the art, and are to beconstrued as being without limitation to such specifically recitedexamples and conditions. Moreover, all statements herein recitingprinciples, aspects, and aspects of the invention as well as specificexamples thereof, are intended to encompass both structural andfunctional equivalents thereof. Additionally, it is intended that suchequivalents include both currently known equivalents and equivalentsdeveloped in the future, i.e., any elements developed that perform thesame function, regardless of structure. The scope of the presentinvention, therefore, is not intended to be limited to the exemplaryaspects shown and described herein. Rather, the scope and spirit ofpresent invention is embodied by the appended claims.

1. A method of manufacturing a communication device including a partialpower source, the method comprising the steps of: depositing a layer ofadhesion material onto a first location of a support structure, whereinthe layer of adhesion material defines a plurality of holes; depositinga first material onto the layer of adhesion material, wherein the firstmaterial adheres to the layer of adhesion material; depositing a layerof transition material onto a second location of the support structure;and depositing a second material onto the layer of transition material,wherein the first material and the second material represent a voltagepotential difference when the first material and the second materialcome into contact with a conducting fluid.
 2. The method of claim 1,wherein the layer of adhesion material is gold.
 3. The method of claim1, further comprising the step of roughing the surface of the adhesionmaterial to enhance adhesion property.
 4. The method of claim 1, whereinthe support structure is a silicon based material.
 5. The method ofclaim 1, wherein the step of depositing the first material includesevaporating deposition using electron beams.
 6. The method of claim 1,wherein the layer of adhesion material is less than 100 microns thick.7. The method of claim 1, wherein the step of depositing a layer oftransition material includes the steps of: depositing the layer oftransition material onto the support structure; heating the supportstructure with the layer of transition material deposit; and cleaning anexposed surface of the layer of transition material such that theresulting structure is ready to receive the second material.
 8. Themethod of claim 7, wherein the step of cleaning the exposed surfacefurther comprises cleaning with an ion gun.
 9. The method of claim 1,further comprising the step of spinning a polymer onto the device toprovide a protective coating.
 10. The method of claim 7, furthercomprising the step of spinning the device to evenly distribute apolymer on the surface of the device.
 11. The method of claim 1, furthercomprising the step of inserting the device into a non-conductingmembrane.
 12. A method of manufacturing a plurality of communicationdevices, wherein each device includes a non-conducting membrane and apartial power source device, the method comprising the steps of: cuttinga plurality of openings into a sheet of non-conducting material toproduce an assembly membrane sheet, wherein the shape of each openingcorresponds to the shape of a framework of the device; and inserting onepartial power source device selected from the plurality of partial powersource devices into each opening of the assembly membrane sheet toproduce a loaded membrane sheet, wherein each partial power sourcedevice is prepared according to a process that includes the step ofdepositing a layer of transition metal on an opposite surface of asupport structure from a surface having an adhesion material.
 13. Themethod of claim 12 further comprising the steps of: depositing a layerof non-reactive material onto the loaded membrane sheet on a sideopposite the transition metal to produce an adhesion membrane sheet,wherein the layer of non-reactive material defines a plurality of holes;depositing a first material onto the adhesion membrane sheet on the sidewith the adhesive material, wherein the first material adheres to thenon-reactive material; depositing a second material onto the layer oftransition metal to produce a partial power device sheet, wherein thefirst material and the second material represent a voltage potentialdifference.
 14. The method of claim 13 further comprising the step ofdefining a plurality of boundaries on the support structure, whereineach boundary corresponds to circuitry of each device.
 15. The method ofclaim 14, wherein the step of depositing a layer of non-reactivematerial further comprises the step of defining a group of holes,wherein each group of holes is contained within one boundary selectedfrom the plurality of boundaries, such that the position of each holewithin the group of holes is within the corresponding boundary.
 16. Adevice comprising a partial power source for communication, wherein thedevice is prepared by a process comprising the steps of: depositing alayer of adhesion material onto a first location of a support structure,wherein the layer of adhesion material defines a plurality of holes;depositing a first material onto the layer of adhesion material, whereinthe first material adheres to the layer of adhesion material; depositinga layer of transition material onto a second location of the supportstructure; depositing a second material onto the layer of transitionmaterial, wherein the first material and the second material represent avoltage potential difference when the first material and the secondmaterial come into contact with a conducting fluid.
 17. The method ofclaim 1, wherein the transitional material is titanium.
 18. A deviceincluding a partial power source for communication, wherein the devicecomprises: a support structure made from a silicon material; and a CuCllayer deposited on a first location of the support structure usingphysical vapor deposition.
 19. The device of claim 18, wherein thephysical vapor deposition is achieved through sputter deposition. 20.The device of claim 18, wherein the physical vapor deposition isachieved through arc deposition.